Kornimate/medical-research-clean huggingface dataset:
adp-a2m4cd8 as monotherapy or in combination with either nivolumab or pembrolizumab in hla-a2+ subjects with mage-a4 positive tumors (surpass)

Conditions: Endometrial Cancer; Esophageal Cancer; Esophagogastric Junction (EGJ); Gastric (Stomach) Cancer; Head and Neck Cancer; Melanoma; Ovarian Cancer; Non-small Cell Lung (NSCLC); Urothelial Cancer

Summary: this study will investigate the safety and tolerability of adp-a2m4cd8 t-cell therapy in subjects who have the appropriate human leukocyte antigen (hla) and mage-a4 tumor antigen. tumor indications include endometrial, esophageal, esophagogastric junction (egj), gastric, head and neck, melanoma, non-small cell lung (nsclc), ovarian or urothelial cancer.

conditions: endometrial esophageal cancer esophagogastric junction (egj) gastric (stomach) head and neck melanoma non-small cell lung (nsclc) ovarian cancer

Eligibility criteria:
* key inclusion criteria * age ≥18 and ≤ 75 years * subject is positive for at least 1 hla-a\*02 inclusion allele * histologically or cytogenetically confirmed diagnosis of urothelial cancer, esophageal, esophagogastric junction (egj) cancer, gastric cancer, non-small cell lung carcinoma (nsclc), head and neck or ovarian cancer, endometrial cancer, melanoma * measurable disease according to recist v1.1 prior to leukapheresis and lymphodepletion. * tumor shows mage-a4 expression as confirmed by central laboratory * ecog performance status of 0 or 1. * left ventricular ejection fraction (lvef) ≥50% or the institutional lower limit of normal range, whichever is lower note: other protocol defined inclusion/exclusion criteria may apply * subjects must have ≥ 90% room air oxygen saturation at rest at screening (within 7 days of leukapheresis) and at baseline. key exclusion criteria * positive for any hla-a\*02 allele other than: one of the inclusion alleles * history of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study * active autoimmune or immune mediated disease * leptomeningeal disease, carcinomatous meningitis or symptomatic cns metastases * other prior malignancy that is not considered by the investigator to be in complete remission. clinically significant cardiovascular disease * uncontrolled intercurrent illness * active infection with human immunodeficiency virus, hepatitis b virus, hepatitis c virus, or human t cell leukemia virus * pregnant or breastfeeding note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: cell therapy t cell therapy spear t cell mage-a4 immuno-oncology metastatic urothelial head and neck gastric (stomach) esophagogastric junction (egj) non-small cell lung (nsclc) esophageal cancer ovarian cancer endometrial cancer melanoma
functional magnetic resonance-based observations of brain networks in moyamoya disease patients under anesthesia

Conditions: Moyamoya Disease

Summary: moyamoya disease is characterized by progressive stenosis of the genesis of the distal internal carotid arteries bilaterally and progressive generation of compensatory pathological vascular networks at the basis cranii, and these pathological vasculature has poor vascular reactivity. perioperative circulatory management of patients with smoky vessels to ensure perfusion of brain tissue and integrity of brain network during surgery to minimize postoperative impairment of neurological functions, including motor, sensory, emotional and cognitive functions, is the key point of perioperative circulatory management of moyamoya disease. functional magnetic resonance imaging (fmri) has been routinely used in various cerebrovascular diseases to further evaluate cerebrovascular reserve and cerebral network connectivity. the purpose of this study is to observe the changes in cerebral blood flow, cerebral oxygen metabolism, cerebral oxygen metabolism rate, and cerebral network connectivity in adult patients with moyamoya disease in cerebral ischemia-sensitive areas under anesthesia to provide a basis for exploring anesthesia management to improve cognitive function and cerebral network connectivity in these patients.


Eligibility criteria:
inclusion criteria: * patients with moyamoya disease scheduled for direct or indirect intracranial and extracranial revascularization surgery * age between 18-65 years * obtain written informed consent. exclusion criteria: * patients with preoperative claustrophobia, sensory or motor aphasia that are unable to understand and cooperate with the examination * preoperative cranial imaging suggesting cerebral infarction lesion diameter \>15mm * patients allergic to anesthetic drugs * metal implants in the body * undergoing other experimental drug or instrumentation trials

Keywords: moyamoya disease cerebral network cognitive function anesthesia
efficacy and safety of methoxyflurane (penthrox) for the treatment of acute pain in minor trauma

Conditions: Acute Pain Due to Trauma

Summary: this study investigates the treatment of acute pain, an unpleasant feeling caused by an injury. the overall purpose of the study is to gain more information that the pain relief medicine penthrox(methoxyflurane) administered using the penthrox inhaler(a distinctive green, whistle like object that you breathe through) is safe and works at relieving pain in patients aged 12 years and older who are admitted to a hospital emergency department with a minor injury (known as trauma).


Eligibility criteria:
inclusion criteria: * patients 12 years of age or older who are able to give written informed consent or who are accompanied by a parent(s)/legal guardian able to provide written informed consent on their behalf. * evidence of signed and dated informed consent document(s) indicating that the patient (and/or a parent/legal guardian) has been informed of all pertinent aspects of the study. * pain score ≥ 4 to ≤ 7 as measured using numerical rating scale (nrs) at the time of admission, due to minor trauma. exclusion criteria: * life-threatening condition requiring immediate admission in the operating room or intensive care unit. * presence of any other clinical condition(s) that may, in the opinion of the investigator, impact on the patient's ability to participate in the study, or on the study results, including history of head injury and/or altered consciousness. * unable to provide written informed consent. * known pregnancy or lactation * acute intoxication with drugs or alcohol, based on the judgement of the attending physician. * treatment with any analgesic agent within 5 hours prior to presentation to ed (except diclofenac sodium which is prohibited within 8 hours prior to presentation to ed). * current ongoing use of analgesics for chronic pain. * use of an investigational product within one month prior to presentation to ed. * known personal or familial hypersensitivity to fluorinated anaesthetics. * known personal or familial history of malignant hyperthermia. * clinically significant respiratory depression. * use of methoxyflurane in the previous 4 weeks. * known pre-existing clinically significant renal or hepatic impairment according to the judgement of the clinician. * clinically significant cardiovascular instability.

Keywords: pain trauma analgesia
phase ii study of bevacizumab, pemetrexed and carboplatin as first-line therapy in malignant pleural mesothelioma

Conditions: Mesothelioma

Summary: the primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression.

secondary endpoints are to evaluate: * the objective response rate (rr) of the combination; * the toxicity and the safety profile of the combination; * the duration of response (rd) and time to treatment failure (ttf); * the overall survival (os) * rr, ttp and os according to baseline plasma vegf levels (introduced with amendment 1 dated 8/11/2007)

Eligibility criteria:
inclusion criteria: * histologically proven malignant pleural mesothelioma, inoperable, non previously treated with chemotherapy including intracavitary administration * ps 0-1 * measurable and/or evaluable lesions according to recist criteria * adequate organ function exclusion criteria: * uncontrolled hypertension * evidence of bleeding diathesis or coagulopathy * pregnancy or breast-feeding
a randomized, open, comparative multicenter study of initial treatment with intravenous itraconazole versus amphotericin b followed by consolidation treatment with itraconazole capsules in patients with blastomycosis or histoplasmosis

Conditions: HIV Infections; Histoplasmosis; Blastomycosis

Summary: to assess the safety of intravenous itraconazole compared to amphotericin b in hiv positive or negative persons with blastomycosis or histoplasmosis.

patients are randomized to receive iv itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin b daily for 7 days. iv treatment is followed by consolidation with oral itraconazole for up to 1 year.

Eligibility criteria:
inclusion criteria patients must have: * hiv positive or negative status. * blastomycosis or histoplasmosis. * life expectancy of at least 1 week. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * liver disease. * self-limiting fungal disease. * very severe fungal disease such as meningeal involvement. * acute respiratory disease. concurrent medication: excluded at any time: * terfenadine. * astemizole. * oral midazolam. * triazolam. * cisapride. * phenytoin. * phenobarbital. * rifampin. * rifabutin. excluded during oral consolidation: * h2 blockers. * chronic antacids. * omeprazole. * lansoprazole. patients with the following prior condition are excluded: hypersensitivity to azole antifungals. prior medication: excluded at any time: more than 3 days of amphotericin b, fluconazole, or ketoconazole. excluded within 2 weeks prior to study entry: * phenytoin. * phenobarbital. * rifampin. * rifabutin.

Keywords: itraconazole histoplasmosis antifungal agents acquired immunodeficiency syndrome amphotericin b aids-related complex blastomycosis antibiotics, antifungal
photo biostimulation and spasticity in cerebral palsy

Conditions: Cerebral Palsy; Cerebral Palsy, Spastic

Summary: the current study will address the spasticity in calf muscle secondary to cerebral palsy in children. as the spasticity can inversely affect muscle contraction, joint function, and consequently the function and quality of life, the current study will investigate the effect of adding photobiostimulation therapy to standard physiotherapy on muscle tone, ankle range of motion, gross motor function, plantar surface of the affected foot, and quality of life in patients with spastic cerebral palsy

spasticity is one of the common complications associated with upper motor neuron injuries such as cerebral palsy. it can affect the normal developmental process of the child as it restricts muscle performance, limit range of motion, decrease function, and affect the ability to engage in daily activities. the current study will include 2 groups of children having spastic cerebral palsy. these groups will be randomly distributed to the experimental group (receive standard physiotherapy treatment plus photo biostimulation therapy on related acupuncture points) and the control group will receive a standard physiotherapy program. the duration of the intervention will be 1 month, 3 sessions per week. the outcome measures will be assessed at baseline, at the end of the intervention ( after 4 weeks of treatment), and at 3 months follow-up.

Eligibility criteria:
inclusion criteria: * age between 8 and 14 years, * who had a diagnosis of spastic cerebral palsy by a pediatrician, with at least one spastic - muscle in the extremities, * grades 1 -4 on gross motor function classification system * score 1 on the modified ashworth scale (mas) * the ability to walk alone or with assistance * whose parents/guardians sign the informed consent form, * who were willing to complete the study. exclusion criteria: * patients with anatomical disorders, * patients who received a botulinum toxin injection in the calf muscle during the last six months * surgery in the lower extremity during the previous year * severe associated neurological diseases such as epilepsy * poor nutritional status,
clinical variables and dyspnea and fear of movement in chronic obstructive pulmonary patients

Conditions: COPD; Kinesiophobia Due to Dyspnea

Summary: patients diagnosed with copd who applied to the pulmonary diseases department of kırıkkale yüksek i̇htisas hospital will be included in the study. the aim of our study: it is aimed to investigate the effect of fear of movement due to dyspnea on respiratory function, muscle strength, physical performance and balance in chronic obstructive pulmonary disease patients.

at kırıkkale yüksek i̇htisas hospital, individuals with copd who meet the inclusion and exclusion criteria and volunteer to participate in the study will be included. the number of patients to be included in our study will be determined by power analysis. sociodemographic information (age, gender, body mass index, smoking history) of the individuals included in the research will be recorded. regarding copd symptoms: whether the cough is productive or non-productive, its frequency and period presence of sputum, type, amount, color, presence of hemoptysis, presence of chest pain, presence of peripheral edema, you will be asked about the presence of resting and/or exertional dyspnea, orthopnea, paroxysmal nocturnal dyspnea (pnd). 1. respiratory muscle strength: it will be measured using an electronic, mobile, intraoral pressure measuring device. 2. peripheral muscle strength evaluation: quadriceps muscle strength will be evaluated using a dynomometer. 3. physical performance: a 6-minute walk test will be used to determine the physical fitness levels of individuals. 4. balance level: mini-best test will be used to determine the balance level 5. kinesiophobia level due to dyspnea: it will be evaluated with the breathlessness beliefs questionnaire (bbq). when the literature was examined, no study was found that examined all of these factors together in patients with copd. existing studies have shown that the effects of variables are different and it is stated that more studies are needed.

Eligibility criteria:
inclusion criteria: * being diagnosed with copd be clinically stable for the last four weeks not using antibiotics for the last four weeks being over 45 years old, volunteering to participate in the study exclusion criteria: * not being able to cooperate with the evaluations to be made, having any physical disability that may affect walking and balance having severe neuromuscular, musculoskeletal and rheumatological problems accompanying copd

Keywords: chronic obstructive pulmonary disease, kinesiophobia, physical performance, dyspnea
myopia control combined pbm with myopic defocus lens in children

Conditions: Myopia, Progressive

Summary: to study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.

myopic children with age from 6 \~13 years old. and refraction from -0.50d\~-5.50d. the red light is low lever laser therapy at wavelength of 650nm.

Eligibility criteria:
inclusion criteria: * informed consent by the supervision of the children * 6\~13 years old (including both the 6 and 13) * se range: -0.50\~-5.50d * astigmatism \<=2.00d * bcva \>=0.8 * anisometropia \<=1.50d * confirmed to no use of other myopia control intervention exclusion criteria: * ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.) * halo, glare, toutic, adhd, psoriasis * systom disease: immune disease, central nerve system, down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction. * squint, ocular lesion or acute imflammation. * other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.
ovrcome - self guided virtual reality for social anxiety disorder

Conditions: Social Anxiety

Summary: social anxiety is characterised by excessive fear of being negatively judged, embarrassed or humiliated during social interactions and is common with a lifetime prevalence of 12.1%. cognitive behavioural therapy is the first line of treatment, but people may not seek treatment due to a number of factors including the discomfort experienced in seeking help, inconvenience, and the experience of psychotherapy itself. with virtual reality (vr), users can have increased control in how gradually they expose themselves to social situations. in studies of vr in people with specific phobias, 76% of people prefer vr exposure to in vivo exposure. there is emerging evidence for the use of vr in social phobia. ovrcome, is a self-help vret for social anxiety symptoms and specific phobias, that is delivered through a smartphone application (app) in combination with a low cost headset that holds the smartphone and uses 360º video. this study will evaluate the effectiveness of the ovrcome social anxiety program for social anxiety symptoms. we hypothesize that ovrcome will reduce social anxiety symptom severity over a 6-week treatment period compared to waiting-list control


Eligibility criteria:
inclusion criteria: * are between 18-64 years old * have moderate (or higher) social anxiety disorder symptoms on liebowitz social anxiety scale (\>60) * have access to a smart phone and internet * willing to participate in the research study and providing informed consent exclusion criteria: * present with symptoms of severe depression or suicidality respectively as measured with the phq-9; total score \> 19, =3 on suicidality item * have insufficient knowledge of the english language * are under current treatment for social phobia or psychotropic medication (unless on stable dosage for the previous 3 months and no changes planned during the study period).
evaluation of local anlagesia into the trocar site during operative laparosocpy

Conditions: Pain

Summary: in the literature there is conflicting data on administration of local analgesia in addition to the general anesthesia to the trocar sites during laparoscopy, we believe that adding local analgesia to the general anesthesia during laparoscopy is beneficial . the current study will evaluate prospectivly the impact of local analgesia on postoperative pain and recovery in patients undergoing operative laparoscopy

methods: this is a blinded prospective randomized study. after approval of irb and informed consent 120 patients undergoing for laparoscopy will be randomized after the induction of general anesthesia into three groups: group a will receive preemptive analgesia using 3-5 cc of 0,5 % marcaine at the beginning of the procedure. group 2 will receive a local analgesia using 3-5 cc marcaine at the end of the procedure. group 3 will be operated under general anesthesia only. the post operative pain and patient recovery will be assessed by the nurses during the hospitalization using a vas (visual analog scale) the total analgetic drugs will be noted and after the patients discharge the patient status and satisfaction will be evaluated by phone up to 2 wks

Eligibility criteria:
inclusion criteria: * female older then 18 y/o exclusion criteria: * allergy to marcaine

Keywords: laparoscopy preemptive postoperative pain trocar site
cerebral microemboli in venoarterial ecmo patients

Conditions: Complication of Extracorporeal Membrane Oxygenation; Cerebral Microembolism; Cerebral Perfusion

Summary: extracorporeal membrane oxygenation (ecmo) is progressively used in critically ill patients with cardiac or respiratory failure as a bridging option for potential organ recovery. however, ecmo survivors often suffer from poor neurocognitive outcome due to neurological complications such as microembolic (me) strokes. in venoarterial (va) ecmo circuits the pulmonary circulation, which usually serves as microembolic filter, may be bypassed and generated me are prone to reach the brain in substantial amounts and potentially impair cerebral integrity. although patient exposure to cerebral me has been thoroughly investigated in cardiopulmonary bypass procedures, there is only limited research on cerebral me in patients undergoing ecmo therapy. the primary study goal of this study is to determine the load and nature of cerebral me in critically ill patients under va-ecmo support. we also aim to compare the results to measurements in healthy subjects und intensive care unit (icu) patients without extracorporeal support to get a better impression on the relevance of me generation during ecmo support.

the addition of icu patients was made according to reviewer suggestions after an initial submission to a medical journal.

Eligibility criteria:
inclusion criteria (for patients): * intensive care patients with cardiac or respiratory failure under va-ecmo therapy * age \> 18 yrs. * signed informed consent exclusion criteria: * use of any other extracorporeal device including venovenous (vv) ecmo * continuous renal replacement therapy * medical history of severe mitral or aortic stenosis * medical history of severe mitral or aortic regurgitation * medical history of carotid stenosis \> 70 % * septicaemia * medical history of vascular dementia or alzheimer's disease * inclusion in an other clinical study * gravidity * allergy against materials of one of the medical device used in the study
skin ulcers treatment with an handicraft topical device

Conditions: Foot Ulcer; Varicose Ulcer

Summary: the aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.

the hypothesis of this trial is that the handicraft topical device of negative pressure is even better for the treatment of skin ulcers located in the lower limbs of patients with diabetes mellitus, venous stasis and arterial insufficiency. we anticipate that in a sample of 144 patients with ulcer, will heal or at least improve with this treatment

Eligibility criteria:
inclusion criteria: 1. patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital no. 17, instituto mexicano del seguro social, benito juárez, quintana roo. 2. patients of both sexes. 3. patients over 18 years. 4. patients that have basic laboratory at admission (complete blood count with differential). 5. patients with comorbidities associated as diabetes mellitus , hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc. exclusion criteria: 1. hemodynamically unstable patients. 2. patients with septic shock from any source. 3. patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure. 4. patients with secondary cutaneous ulcer enteral fistula. 5. patients with cutaneous ulcer or cancer tumors. 6. patients with cutaneous ulcer with active bleeding. 7. patients with cutaneous ulcer necrosis. 8. patients with cutaneous ulcer leishmania, insect bite. 9. patients with cutaneous ulcer burns. 10. patients who do not accept their participation in the study through informed consent.

Keywords: diabetic foot ulcer foot care wound management